Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- B Braun Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- B Braun Medical
- Product type
- IV Administration Set
- Model numbers
- Catalog Number: 490354, Primary UDI-DI: 04046964602382, Unit of Dose UDI-DI: 04046964602375
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 29, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
IV administration sets are used to deliver fluids and medications through IV lines in hospital and clinical settings. They connect to IV bags or pumps and are selected based on compatibility with infusion devices.
Why This Is Dangerous
Backflow into the primary IV line can lead to medication misadministration or contamination. Inability to prime can disrupt flow and dosing.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Hospitals and clinics may need to quarantine affected lots and switch to alternatives, impacting inventory and workflow.
Practical Guidance
How to identify if yours is affected
- Verify Catalog Number 490354 on the device label.
- Check Primary UDI-DI 04046964602382 and Unit of Dose UDI-DI 04046964602375 on packaging.
- Review the recall notice sent by mail for instructions.
Where to find product info
UDI numbers, catalog numbers, and expiration on device packaging and recall notices.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after submission of the recall claim.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- File a complaint with the FDA or relevant health authority if the company remains unresponsive.
- Consult legal counsel if necessary.
How to prevent similar issues
- Verify device compatibility with infusion pumps before purchase.
- Maintain an updated inventory of IV sets and verify backflow prevention features.
- Follow all device recalls promptly.
- Check for any new recall notices from the manufacturer.
Documentation advice
Keep recall notice, purchase records, batch/lot numbers, and correspondence with the manufacturer as part of the record.
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Product Details
Catalog Number: 490354. Primary UDI-DI: 04046964602382. Unit of Dose UDI-DI: 04046964602375. Expiration Date: Earliest Exp of Comp or 24mths. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore. Quantity: 41,976 units. Brand: B Braun Medical.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964602375
- Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore)
- Hazard: backflow and occlusion risk
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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